MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number	G407209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
While recovering from an atrial fibrillation ablation procedure, a cardiac perforation was noted.During the procedure, while attempting the transseptal puncture, aortic pressure was recorded.The sheath was not advanced.The needle was retracted and a second pass was successful in gaining access to the left atrium.The procedure was completed successfully and the patient was stable throughout with no negative consequences observed.There were no performance issues with any abbott device during the procedure.The physician reported that later that night the patient experienced a tamponade on the ward.A pericardiocentesis was performed and the patient is now stable and recovering.Based on the location of the tamponade, it is suspected that it occurred during the aortic puncture.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17977734
• Report Number: 3008452825-2023-00484
• Device Sequence Number: 14332279
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: (01)05414734205184(10)8948101(17)260228
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 8948101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 07/10/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/29/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown